High Performance Liquid Chromatographic Determination of Naproxen in Prepared Pharmaceutical Dosage Form and Human Plasma and its Application to Pharmacokinetic Study

Abstract

A simple, fast, economical and precise reverse phase liquid chromatographic method was developed, optimized and validated for quantification of naproxen sodium according to the standard guidelines. The separation of the analyte and internal standard was achieved over C-18 column using acetonitrile: water: glacial acetic acid as mobile phase in a ratio of 50:49:1 (v/v) in isocratic mode at a flow rate of 1.2 mL/min at a wavelength of 254 nm at ambient temperature. The retention time was found to be less than 10 minutes. The limit of detection (LOD) was 10 ng/mL and limit of quantification (LOQ) was 15 ng/mL. Naproxen sodium was extracted from biological samples by using acetonitrile as extraction solvent. The linearity was found to be 0.5 to 80 ppm. All the parameters were validated for accuracy, precision, linearity, sensitivity, reproductivity and stability. The method was successfully applied for the quantification of the naproxen sodium in animal and human plasma. Therefore, the method was found to be accurate, reproducible, sensitive, cost effective, less time consuming and can be successfully applied on routine analysis of naproxen sodium in pharmaceutical formulations and pharmacokinetic studies in human and animal models.